Director / Senior Director, DMPK

The role

The Director or Senior Director of DMPK provides scientific and strategic leadership for drug development. This person evaluates potential in-licensing opportunities and provides DMPK leadership for advanced preclinical and clinical pipeline programs.

What you will do

• Serve as DMPK subject-matter expert for scientific diligence of potential in-licensing, acquisition, and partnership opportunities.
• Evaluate nonclinical and clinical PK, ADME, metabolism, transporter, bioavailability, PK/PD, and exposure-response datasets.
• Assess the quality and completeness of available data to identify development risks.
• Evaluate human PK characteristics, dose projections, therapeutic margins, and DDI potential.
• Integrate DMPK findings with pharmacology, toxicology, clinical, CMC, and regulatory information.
• Develop recommendations for cross-functional diligence teams and senior leadership.
• Define priority experiments and analyses needed during diligence.
• Provide DMPK leadership for advanced preclinical and clinical-stage programs.
• Develop DMPK strategies from late preclinical development through IND/CTA and clinical stages.
• Provide scientific oversight of CROs, consultants, and other external partners.

Required qualifications

• PhD in pharmaceutical sciences, pharmacokinetics, pharmacology, chemistry, biochemistry, or a related discipline, or an equivalent combination of education and experience.
• 8+ years of relevant biotechnology or pharmaceutical industry experience.
• Deep expertise in DMPK with substantial experience supporting development-stage small-molecule programs.
• Demonstrated experience integrating nonclinical and clinical PK data to guide drug-development decisions.
• Strong understanding of ADME, clearance mechanisms, drug metabolism, transporters, absorption and bioavailability, protein binding, tissue distribution, and drug-drug interactions.
• Experience with human PK prediction, PK/PD and exposure-response analysis, and clinical translation.
• Strong working knowledge of regulatory expectations for DMPK and clinical pharmacology during drug development.
• Experience evaluating complex datasets and making recommendations when information is incomplete, inconsistent, or evolving.
• Demonstrated ability to work effectively with external CROs, consultants, and partners.
• Excellent written and verbal communication skills.

Nice to have

• Direct experience supporting first-in-human and subsequent clinical studies

Benefits

• Equity
• Comprehensive benefits
• Generous perks

Before you apply

• Please apply only if you reside in New York City, Boston metro areas, Research Triangle (NC), or San Francisco Bay Area or are willing to relocate.

About the company

Formation Bio is a tech and AI driven pharma company that builds technology platforms, processes, and capabilities to accelerate drug development and clinical trials.